Compositions comprising salbutamol sulphate

Patent metadata

Field	Value
Publication number	US-2017165367-A1
Application number	US-201615357279-A
Country	US
Kind code	A1
Filing date	Nov 21, 2016
Priority date	Oct 12, 2011
Publication date	Jun 15, 2017
Grant date	—

Abstract

A pharmaceutical composition is described that is suitable for delivery from a pressurised container. The composition is free of polar excipients and comprises: (a) a propellant component that consists essentially of 1,1-difluoroethane (R-152a); (b) a surfactant component that comprises oleic acid; and (c) a drug component that consists of salbutamol sulphate. The pharmaceutical composition can be delivered using a metered dose inhaler (MDI).

First claim

1 . A pharmaceutical composition that is free of polar excipients, said composition comprising:
(a) a propellant component consisting essentially of 1,1-difluoroethane (R-152a), (b) a surfactant component comprising oleic acid; and (c) a drug component consisting of salbutamol sulphate.

2 . The pharmaceutical composition of claim 1 which consists essentially of components (a), (b) and (c).

3 . A pharmaceutical composition for delivery from a pressurised container, said composition consisting essentially of:
(a) a propellant component consisting essentially of 1,1-difluoroethane (R-152a), (b) a surfactant component comprising oleic acid; and (c) a drug component consisting of salbutamol sulphate.

4 . The pharmaceutical composition of claim 1 or claim 3 which consists entirely of components (a), (b) and (c).

5 . The pharmaceutical composition of any one of the preceding claims, wherein the propellant component consists entirely of 1,1-difluoroethane (R-152a).

6 . The pharmaceutical composition of any one of the preceding claims, wherein the surfactant component consists entirely of oleic acid.

7 . A sealed container that contains a pharmaceutical composition as claimed in any one of claims 1 to 6 .

8 . The sealed container of claim 7 which is a pressurized container for use with a metered dose inhaler (MDI).

9 . A metered dose inhaler (MDI) fitted with a pressurized container as claimed in claim 8 .

10 . A method for treating a patient suffering or likely to suffer from a respiratory disorder which comprises administering to the patient a therapeutically or prophylactically effective amount of a pharmaceutical composition as claimed in any one of claims 1 to 6 .

11 . The method of claim 10 , wherein the respiratory disorder is asthma.

12 . The method of claim 10 or claim 11 , wherein the pharmaceutical composition is delivered to the patient using a metered dose inhaler (MDI).

13 . A method for manufacturing a pharmaceutical composition as claimed in any one of claims 1 to 6 , said method comprising the steps of:
introducing a weighed amount of the drug component into an open container from which the drug component will ultimately be released as an aerosol spray using a medication delivery device;
fitting a valve device onto the container;
introducing the propellant component, in liquid form, through the valve into the container under pressure; and
introducing the surfactant component through the valve into the container under pressure.

Assignees

• Mexichem Amanco Holding Sa

Inventors

• Corr Stuart
• Noakes Timothy James

Classifications

• A61K47/12

  Carboxylic acids; Salts or anhydrides thereof · CPC title

• A61K9/008 Primary

  comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI] · CPC title

• A61K31/137

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title

• A61P11/00

  Drugs for disorders of the respiratory system · CPC title

• A61M15/009

  using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08) · CPC title